Manager/Sr. Manager - Medical Writing
- Experience Level
- Experienced (non-manager)
Manage the team of medical writers. Compose scientific, educational, research and regulatory documents for Medical Writing client projects and healthcare websites. Break down complex concepts and medical jargon and write for the level of understanding for the specific target audience. To provide quality regulatory documents within budget.
Specific job duties:
- Provide support and management of Medical Writing group
- Prepare and edit Phase 1 through IV regulatory and post marketing documents including clinical protocols, clinical study reports, study synopses, IND, NDA and MAA submission documents, safety narratives, registry reports, observational studies, risk evaluation and mitigation strategy (REMS) assessment reports, knowledge, attitude, and behavior surveys (KABS), and abstracts/manuscripts for publication.
- Peer review regulatory documents.
- Participate in UBC and client project teams for project planning and development of timelines.
- Coordinate/consult with other UBC departments such as SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management on Medical Writing projects.
- Prepare and review departmental standard operating procedures (SOPs).
Team of medical writers (between 4-8 resources)
Desired Skills and Qualifications:
- Master's degree in biological sciences or equivalent
- 8-10 years of experience with at least 4 years’ experience in medical regulatory writing or equivalent within the pharmaceutical/CRO industry
- Supervisory experience preferred but not required
- Word processing skills (Microsoft Word)
- Knowledge of medical terminology and understanding of the clinical trial process
- Ability to interpret clinical data and strong analytical skills
- Strong organization and prioritization skills
- Attention to detail/high degree of accuracy
- Good communication and interpersonal skills
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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